About the AuthorMy name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in New York. For the past several years, I have been consulting with pharmaceutical and biologic companies that are engaged in the process of bringing new drugs to market. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.
My ProfileI am an authority on regulatory aspects of communications and medical products, with particular emphasis on pre-approval communications; strategist to help pharma and biotech companies prepare best case for advisory committee approval; and counselor in issues and crisis management. I am a frequent speaker on various aspects of same - drug development, promotion, reimbursement and new media in a highly regulated environment. Author of books, newspaper and magazine pieces related to drug marketing and promotion as well as HIV specialty pieces. And of course... blogger!
About This Blog
Eye on FDA is published by Mark Senak of FleishmanHillard’s New York office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of FleishmanHillard or its clients.
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Monthly Archives: November 2009
77 Percent Transparency on FDA’s Advisory Committees
With great fanfare, the FDA launched a transparency initiative early this year. The activities included the formation of a Transparency Task Force, the creation of a Transparency Blog, not one but two public meetings held on the subject of transparency, … Continue reading
Posted in Uncategorized 3 Comments
Stick a fork in me, I'm done! I'm taking the rest of the week off for the holiday. In the meantime, I wish for each and every one of you a safe, tasty and pleasant Thanksgiving holiday in the states, … Continue reading
Posted in Miscellaney 5 Comments
In the wake of the FDA's Part 15 meeting on social media, all eyes are on the horizon to see what is to come. FDA's Janet Woodcock said at the FDLI Conference this fall that the issue of social media, … Continue reading
Posted in Uncategorized 1 Comment
Weekly Roundup – 11-20-09
Ok, I'm two days late and a dollar short. It was busy last week. And then there is this thing called my job, which someone actually expects me to do, at least now and then. But some interesting stuff went … Continue reading
Posted in Uncategorized Comments Off on Weekly Roundup – 11-20-09